Hepatitis b vaccine recombinant, adjuvanted (Intramuscular)

Hepatitis B vaccine is used to prevent infection caused by all known subtypes of the hepatitis B virus.

This vaccine should be given by your doctor or under their direct supervision.

It is important for your doctor to check how you are doing to ensure this medicine is working correctly. Blood tests may be necessary to look for any unwanted effects.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and need immediate medical help. Inform your doctor right away if you experience a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after getting the vaccine.

Make sure to tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a vaccine, you and your doctor should consider the risks of the vaccine compared to the benefits. For this vaccine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the effects of hepatitis B vaccine in children. Safety and effectiveness have not been proven.

Geriatric

Studies done so far have not shown any specific problems in older adults that would limit the usefulness of the hepatitis B vaccine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together. In other cases, two different medicines can be used together, even if there may be an interaction. In such situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this vaccine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to yeast—Heplisav-B® should not be used in patients with this condition.

• Hepatitis B infection, whether active or unrecognized, or
• Weak immune system—This may reduce the vaccine's effectiveness and the body's response to it.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Contact your doctor or nurse right away if any of the following side effects occur:

Rare

• Chest pain or discomfort
• Inability to move the arms and legs
• Nausea
• Pain or discomfort in the arms, jaw, back, or neck
• Sudden numbness and weakness in the arms and legs
• Sweating
• Vomiting

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Chest tightness
• Cough
• Difficulty swallowing
• Dizziness
• Fast heartbeat
• Hives, itching, skin rash
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Stomach pain
• Trouble breathing
• Unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also offer ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Difficulty in moving
• General feeling of discomfort or illness
• Headache
• Joint pain
• Muscle aches, cramps, pains, or stiffness
• Pain or tenderness at the injection site
• Swollen joints

Less common

• Fever
• Redness or swelling at the injection site

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Heplisav-B
• Prehevbrio

Available Dosage Forms:

• Solution
• Suspension

Therapeutic Class: Vaccine

A nurse or other trained health professional will give you this medicine. It is given as a shot into one of your muscles, usually in the deltoid (upper arm).

Prehevbrio™ is given in 3 doses. The first 2 doses are given at least 1 month apart. The third dose is given at least 6 months after the first dose. Heplisav-B® is given in 2 doses, at least 1 month apart. To get the best possible protection against infection with the HBV virus, you should complete your vaccine dosing schedule.